letibotulinumtoxina

REMS

Temporary improvement in the appearance of moderate to severe glabellar lines (brow furrow) associated with corrugator and/or procerus muscle activity.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Presence of infection at planned injection sites.

Use Cautiously in:

Cardiovascular disease;
Peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) (↑ risk of significant systemic effects such as dysphagia or respiratory compromise);
Swallowing or breathing problems (↑ risk of dysphagia or dyspnea);
Inflammation at planned injection site;
Excessive weakness or atrophy in target muscles;
Marked facial asymmetry, ptosis, excessive dermatochelasis, deep dermal scarring, thick sebaceous skin, or inability to lessen glabellar lines by physical spreading;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

EENT: blepharospasm, brow droop, dry eye, eyelid droop, eye irritation, photophobia, visual changes

GI: dysphagia

Local: distant spread of toxin effect, injection site reactions

Neuro: headache

Resp: dyspnea

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Neuromuscular effects may be potentiated by aminoglycosides, anticholinergic drugs and muscle relaxants.
Additive effects may occur with other forms of botulinum toxin.

Availability ⬆ ⬇

Powder for injection: 50 units/vial; 100 units/vial

Route/Dosage ⬆ ⬇

LetibotulinumtoxinA is NOT interchangeable with any other botulinum toxin product.
IM (Adults ): 0.1 mL (4 units) into each of five sites (two in each corrugator muscle and one in the procerus muscle; total dose of 20 units); not more frequently than every 3 mo.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Produces partial chemical denervation by inhibiting the release of acetylcholine. Result is local decrease in muscle activity.

Therapeutic effects:

Decreased brow furrow with improved appearance.

Classifications ⬆ ⬇

Therapeutic Classification: cosmetic agents

Pharmacologic Classification: neurotoxins

Pharmacokinetics ⬆ ⬇

Absorption: Minimal systemic absorption; action is primarily local.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(improvement)

ROUTE	ONSET	PEAK	DURATION
IM	unknown	unknown	3–4 mo

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of letibotulinumtoxinA. Advise patient to read Patient Information before starting therapy.
Inform patient that the medication has the potential to spread from the injection site to distant parts of the body. May occur within hr or several wk after injection. Advise patient to notify health care professional immediately if swallowing, speech, or respiratory disorders arise.
May cause loss of strength, muscle weakness, blurred vision, or drooping eyelids. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇